NCT05926856

High Quality Fluorescent Cholangiography

Comparison of the Fluorescent Visualization of the Extrahepatic Biliary Tract Between Two Injection Protocols

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled trial is to compare the quality of extrahepatic biliary fluorescent visualization under two injection protocols to optimize extrahepatic biliary cholangiography.

Detailed description

Biliary fluorescence imaging is widely used to identify the extrahepatic biliary tract during laparoscopic cholecystectomy. However, fluorescent developer Indocyanine Green（ICG） still lacks standardization, and not every visualization of the extrahepatic biliary tract is satisfactory. Some research groups have shown that injection of ICG 1 day before surgery can achieve the best fluorescence imaging of the biliary tract, but some research groups have suggested that injection of a very low dose of ICG 45 minutes before surgery can improve the satisfaction of fluorescence imaging. However, no study compares the quality of biliary fluorescence imaging between the two injection protocols. This study will compare the fluorescence imaging effects of the two schemes to obtain the best injection scheme at present and standardize the use of icg.

Conditions

• Extrahepatic Biliary Tree Injury

Interventions

Type	Name	Description
DRUG	Indocyanine green	Indocyanine Green 25mg kit for injection

Timeline

• Start date: 2023-08-04
• Primary completion: 2023-12-11
• Completion: 2023-12-11
• First posted: 2023-07-03
• Last updated: 2023-12-18

Locations

1 site across 1 country: China